Product code QTE
- Device name
- Thymidine Kinase Activity
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.6010
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.
- Source
- FDA openFDA device classification dataset